Associate Manager, Advanced Quality (New Product Development)

Stryker is hiring an Associate Manager, Advanced Quality for our Orthopedic Instruments you will be responsible for leading a team of Advanced Quality Engineers supporting new product development within. You will have cross functional responsibility and work closely with business unit leadership to deliver predictable, quality product launches.

Workplace Flexibility: Candidate must reside within a commutable distance to Portage, Michigan but is expected to be onsite at the facility multiple times/week.

What you will do

• Lead, develop, and engage a high‑performing Advanced Quality Engineering team, including recruiting top talent, driving performance, and providing ongoing coaching and feedback.

• Oversee the development, coordination, and continual improvement of QA systems supporting new product development and business growth initiatives.

• Provide strategic Quality leadership across cross‑functional NPD teams, ensuring alignment with regulatory requirements, design controls, and QMS standards.

• Direct Quality‑owned deliverables such as risk management, human factors engineering, design verification/validation, and compliance activities.

• Guide process development and PPAP execution to ensure robust manufacturing readiness and supplier quality.

• Train cross‑functional teams on QA, GMP, and Design Control practices to elevate organizational capability.

• Operate autonomously, making sound business decisions while maintaining a high level of team engagement and accountability.

What you need

Required

• Bachelor’s degree

• Minimum of 6 years of experience in a regulated environment, preferably within RA/QA, engineering, or related technical disciplines.

Preferred

• Bachelor’s degree in mechanical, electrical, or biomedical engineering, or related discipline.

• Demonstrated leadership experience managing teams, including responsibility for recruiting, performance management, and employee development.

• Experience in new product development, including design controls, risk management, human factors engineering (HFE), and application of regulatory requirements such as ISO standards, FDA regulations, and international guidelines.

• Demonstrated technical expertise in medical device product lines, with proficiency in quality concepts (CAPA, audits, statistics), process improvement, and trending/analysis reporting.